NCT01886456Unknown不适用
Effect of Patterned Laser Trabeculoplasty on Intraocular Pressure Compared to Selective Laser Trabeculoplasty in Treatment Naiv Patients Suffering From Open-angle Glaucoma or Ocular Hypertension
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Intraocular pressure 6 months after Intervention
研究概览
简要总结
To investigate the effect of patterned laser trabeculoplasty (PLT) compared to selective laser trabeculoplasty (SLT) on intraocular pressure (IOP) in treatment naiv patients suffering from open-angle glaucoma or ocular hypertension.
Values for IOP will be measured at baseline, 1 day and 1 month post-interventional as well as 2, 3, 6, 9, 12, 18 and 24 months after treatment.
- Trial with medical device
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intraocular pressure (treatment naiv or after 4 weeks wash-out phase) > 21 mm Hg
- •visible angle structures over 360° on gonioscopy
- •age = 18 years
排除标准
- •Intraocular Inflammation
- •patients who underwent refractive corneal surgery for any reason or who underwent ocular surgery to reduce intraocular pressure (e.g. trabeculectomy)
- •monocle situation
- •anterior chamber lenses (incl. iris claw)
- •secondary glaucoma (with the exception of pseudoexfoliation and pigment dispersion)
研究组 & 干预措施
PLT
Experimental
patients treated with patterned laser trabeculoplasty
干预措施: Laser trabeculoplasty (Device)
SLT
Active Comparator
patients treated with selective laser trabeculoplasty
干预措施: Laser trabeculoplasty (Device)
结局指标
主要结局
Intraocular pressure 6 months after Intervention
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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